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ECO Publishes Suggested Amendments on the Currently Proposed Legal Text of the European Health Data Space Regulation

15 November 2022

In November 2022, the European Cancer Organisation (ECO) published a position document containing suggested amendments on the currently proposed legal text of the Regulation.  

The proposed amendments include 6 key points:  

  1. Ensure that the legislation mandates that the EHDS Board includes stakeholder representation, including for patients and healthcare professionals.  

  2. Require the European Commission to conduct a study on the impact of the General Data Protection Regulation upon cancer research in Europe, including the divergence of implementation approaches, and with provision of remedial recommendations.  

  3. Require explicit time-based targets for implementation and progress on cross-border health data interoperability, including for cancer registry interoperability.  

  4. Include in the legislation understanding that EU funding support, from a range of sources, will be made available to assist all health data systems in the EU prepare and be in a state of readiness for the introduction of the European Health Data Space.  

  5. Make clear in the legislation that the EHDS Board has mandate to explore connections with health systems outside of the EU for the purposes of creating and maintaining a highly effective health data space with maximised benefits for patients.  

  6. Ensure that lessons are learned from implementation difficulties associated with other legislative initiatives, such as GDPR. This includes ensuring that terms and definitions within the legislation are appropriately and tightly described.  

Read the full position document here.

For any information, please contact Silvia Romeo (Policy Officer) at silvia.romeo@europeancancer.org.